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    Home > Active Ingredient News > Drugs Articles > Weishi technology teaches you how to use isolator gloves and dry box gloves well

    Weishi technology teaches you how to use isolator gloves and dry box gloves well

    • Last Update: 2019-12-21
    • Source: Internet
    • Author: User
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    Gloves are the key parts of the isolator equipment Generally, gloves are used to intervene the isolator in the locked state of the operation door according to SOP Gloves are relatively weak parts in isolator structure, and also a risk for sterile environment Therefore, it is necessary to check the integrity of gloves before and after production As for gloves, we are asked more questions: "how long do gloves usually change?" In fact, there are many problems about the gloves on the isolator that we need to consider Today, we will provide some reference information for the use of the gloves on the isolator (1) establish specifications In the process of production process development, we need to list all glove operation actions The intervention actions of these operations need to be verified by dynamic airflow to ensure that the operation will not interfere with the airflow Generally, QA approves these verified operations to be written into SOP and trains specific production personnel Only trained and qualified production personnel can be allowed to perform these operations in the production process (2) record and monitor the use and operation of any gloves in the production process In general, it can send a signal to the control system of the isolator through monitoring video or using the glove mouth with inductive control during operation, so as to record the time point when the specific glove is operated and the duration of continuous operation, so as to provide investigation basis for possible misoperation or other quality events (3) due to the operation interference, there is a pressure difference of 20 ~ 50pA (designed according to the specific process of sterile isolator) between the isolator and the background environment The use of gloves will interfere with the pressure difference inside the cabin, especially when the volume of the isolator cabin is smaller Therefore, it is necessary to limit the number of gloves to be intervened at the same time, as well as the action range and speed of wearing gloves and operating gloves Generally, it is based on the principle of not interfering with the pressure difference control and the air flow inside the isolator, and it is necessary to establish an acceptable specification according to the actual situation of the process According to the analysis of 483 of FDA in previous years, nearly 90% of the nonconformances against isolators are related to air flow and operation intervention Therefore, special attention should be paid to the use of gloves The operation of gloves needs to design, verify and control the daily standard operation (4) Gloves are damaged and aged At present, most gloves are CSM, which belongs to rubber material Even under normal storage, gloves will age The shelf life of general gloves is 2-3 years See the information provided by the glove manufacturer for details In the actual installation and use, the finger position (finger tip / finger seam / Tiger mouth position) and the installation mouth position of gloves are easy to be damaged, which should be paid attention to in the daily visual inspection The position where gloves are easy to be damaged When using gloves, it should be considered to avoid the pulling of gloves, the collision of hard objects or sharp objects Sometimes, for the convenience of drawing, the operator pinches part of the material of the glove to operate without wearing the glove in place, which will reduce the interference range, and the operator will be more inclined to over pull the glove to reach distant objects, which will cause wear or tear of the glove installation position The gloves of the isolator shall not be directly contacted with the medicine and the packaging of the medicine, but shall be taken by means of tools such as tweezers When the isolator is sterilized by vaporized hydrogen peroxide, the gloves need to be fully supported by a special support frame to avoid the dead angle of sterilization caused by folding fold There are also applications where the isolator gloves are operated with another layer of sterile gloves, which need to be considered by the customer according to the sterile risk and operation convenience (5) daily maintenance and integrity inspection of gloves daily maintenance of gloves should carefully read the supplier's manual, and select appropriate cleaning and sterilization methods according to the material characteristics of gloves And before and after the production of gloves for integrity inspection, this inspection needs to be recorded After the completion of the production of the isolator, the surface microorganism inspection will be done on the glove surface generally, especially with the aging of the glove, even if the material is not damaged, the glove surface may become difficult to clean or sterilize, in this case, we also need to change the glove To sum up, let's go back to the first question, "how long do gloves usually change?" We need to define the replacement frequency of gloves through risk assessment based on the actual working conditions of gloves, combined with the disinfection and sterilization methods of gloves, the frequency characteristics of operation and use, and the historical records of glove integrity as data support Send a few photos of gloves to let you have an intuitive understanding of the isolator gloves Conclusion: the use of isolators has changed the traditional and relatively open aseptic production, brought many restrictions to the operators, resulting in a lot of "operation inconvenience" But it is these "inconveniences to operate" that reduce the pollution risk caused by the "convenience and flexibility" of traditional production It is hoped that through this paper, our users can improve their understanding of glove management, and take preventive measures as a means to reduce the risk of sterility caused by the failure of gloves in the production process.
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